Clinical validation of the BDSx scale with bipolar disorder outpatients

Journal Pre-proof Clinical validation of the BDSx scale with bipolar disorder outpatients

Yamima Osher, Yuly Bersudsky, Norm O'Rourke, Dany Belotherkovsky, Yaacov G. Bachner PII:

S0883-9417(19)30342-5

DOI:

https://doi.org/10.1016/j.apnu.2019.11.002

Reference:

YAPNU 51225

To appear in:

Archives of Psychiatric Nursing

Received date:

31 August 2019

Revised date:

23 October 2019

Accepted date:

9 November 2019

Please cite this article as: Y. Osher, Y. Bersudsky, N. O'Rourke, et al., Clinical validation of the BDSx scale with bipolar disorder outpatients, Archives of Psychiatric Nursing(2019), https://doi.org/10.1016/j.apnu.2019.11.002

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© 2019 Published by Elsevier.

Journal Pre-proof

RUNNING HEAD: BDSx Clinical Validation

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Clinical Validation of the BDSx Scale with Bipolar Disorder Outpatients

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Yamima Osher a, Yuly Bersudsky a, Norm O’Rourke b*

Mood Disorders Clinic, Be’er Sheva Mental Health Center, Faculty of Health

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a

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Dany Belotherkovsky a, Yaacov G. Bachner b

647 7427 b

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Sciences, Ben-Gurion University of the Negev, Be’er Sheva, Israel Tel: +972 8

Department of Public Health and Multidisciplinary Research Center on Aging, Ben-Gurion University of the Negev, Be’er Sheva, Israel Tel: +972 8 640 1401

* Corresponding author: Prof. Norm O’Rourke, Ph.D., Department of Public Health and Multidisciplinary Research Center on Aging, Ben-Gurion University of the Negev, P.O.B. #654, Be’er Sheva, Israel 8410501 Tel: +972 8 6477301 [email protected]

Journal Pre-proof Clinical Validation of the BDSx Scale with Bipolar Disorder Outpatients

Abstract

Purpose: The BDSx (Bipolar Disorder Symptom Scale) is a brief self-report instrument designed for repeated measurement of bipolar disorder (BD) symptoms over time. Previous research indicates that the BDSx measures two depression (cognitive and somatic symptoms) and two hypo/mania factors (affrontive symptoms and elation/loss of

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insight). The purpose of this study was to validate BDSx responses relative to diagnoses of BD mood episodes. Methods: Sixty BD outpatients attending routine clinic appointments

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completed the BDSx, the Hamilton Rating Scale for Depression, the Altman Self-Rating

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Mania Scale, and the Satisfaction with Life Scale. Blind to scale responses by patients, a

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clinic psychiatrist determined if patients were currently symptomatic. Results: BDSx depression and hypo/mania subscales showed good construct validity vis-à-vis clinical

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diagnoses, and concurrent/discriminant validity with other self-report scales. And though not designed as a screening measure, sensitivity for the depression subscale is high at

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88% (6+, 76% specificity), yet lower at 57% for the hypo/mania subscale (5+, 90%

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specificity). Conclusions: The results of this study indicate that BDSx responses distinguish patients experiencing significant depressive and hypo/manic mood episodes. Findings support the psychometric properties of the Hebrew version of this scale. The BDSx enables those with bipolar disorder to monitor their symptoms, gauge symptom variability, and identify factors that proceed and sustain BD symptoms over time. KEY WORDS: BDSx, bipolar disorder, validity, reliability, self-report

Introduction Bipolar disorder (BD) is a chronic mental health condition defined by extremes of mood and mood variability, specifically episodes of depression, hypo/mania or a combination

of

the

two

(American

Psychiatric

Association

[DSM

5],

2013).

Pharmacotherapy remains the primary mode of treatment (Osher, Bersudsky, & Belmaker,

Journal Pre-proof 2010) allowing most with BD to live in the community supported by regular clinical contact (Geddes & Miklowitz, 2013). Yet even with effective pharmacotherapy, 73% with BD will experience 1+ mood episode over 5 years (Schaffer, Cairney, Cheung, Veldhuizen, & Levitt, 2006). And when manic, many with BD lack awareness or symptom insight (da Silva et al., 2015), impeding medication adherence and self-care. The BDSx (Bipolar Disorder Symptom Scale) was developed to enable rapid, repeated and reliable measurement of BD symptoms over time (King et al., 2016); responses are psychometrically equivalent between young and older adults (O’Rourke et al., 2018) with

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good concurrent and discriminant validity vis-à-vis other self-report BD scales (O’Rourke et

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al., 2016). To date, however, the BDSx has not been validated relative to clinical

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assessment of current BD symptomatology (i.e., depressive episode, hypo/manic or

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mixed-states). That was the intent of the current study.

We first translated and back-translated the BDSx from English to Hebrew in accord

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with best practices (Eremenco, Pease, Mann, & Berry, 2018). We recruited outpatients

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with long-standing BD diagnoses at the time of their regular clinical appointments. Participants completed the BDSx along with other BD self-report measures. Patients were

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then assessed by a psychiatrist, blind to questionnaire responses, allowing us to test the sensitivity and specificity of BDSx depression and hypo/mania subscales. Methods

Participants and recruitment Consecutive outpatients were recruited at the Mood Disorders Clinic, Be’er Sheva Mental Health Center between May and October, 2018 (Osher et al., 2010): they were 60 patients previously diagnosed with BD, attending regular clinical appointments (e.g., titrate medication dosages). Exclusion criteria were other mood disorders (e.g., unipolar depression), dementia, or inadequate Hebrew comprehension to complete study questionnaires. Two eligible patients declined participation.

Journal Pre-proof Following routine clinical appointments, the clinic psychiatrist completed the Clinical Global Impressions Scale (CGI; Spearing, Post, Leverich, Brandt, & Nolen, 1997) and other rating scales. Demographic information was gathered from the chart review (e.g., age, sex, country of birth/age at immigration, age at BD onset, ethnicity, education, employment status, living arrangements, comorbid psychiatric and medical conditions, family psychiatric history, current psychotropic medications). This study received ethics approval from the Helsinki Committee of

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Soroka University Medical Center, Beér Sheva, Israel.

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Instruments

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The BDSx (Bipolar Disorder Symptom Scale; O’Rourke et al., 2016) is a brief selfreport scale designed to measure both hypo/manic and depressive symptoms of BD.

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Developed for ecological momentary sampling, BD symptoms are reported in the moment

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where they occur as opposed to retrospective recall/later reported. Specifically, the BDSx asks respondents to indicate how much each of 20 symptom-

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related adjectives reflects how they feel right now, at this moment with responses reported

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as not at all (0), a little (1), or a lot (2). Exploratory and confirmatory factor analyses (O’Rourke et al., 2018) have shown a robust 4-factor model of BDSx responses, consisting of two depression factors (cognitive and somatic symptoms) and two hypo/mania factors (affrontive symptoms and elation/loss of insight). The affrontive symptoms of hypo/mania are correlated with both cognitive and somatic symptoms of depression (O’Rourke et al., 2016). See Figure 1.

FIGURE ONE HERE

Hamilton Rating Scales for Depression HAM-D (clinician and self-report). The HAM-D was originally developed to test the efficacy of the first generation of antidepressants (Hamilton, 1960). The HAM-D has since become the gold standard in

Journal Pre-proof clinical research to measure symptom severity and change over time (Bagby, Ryder, Schuller, & Marshall, 2004; Entsuah, Shaffer, & Zhang, 2002). For this study, the psychiatrist completed the full, clinical version of the HAMD-24 and patients completed a self-report, 6-item HAMD-6 (Bech et al., 2009), previously translated and validated for research in Israel (Bachner, O’Rourke, Goldfracht, Bech, & Ayalon, 2013). Altman Self-Rating Mania Scale. The AMS (Altman, Hedeker, Peterson, & Davis, 1997) is a self-report scale developed to detect the presence and severity of hypo/manic symptoms. Participants select 1 of 5 responses from each of 5 groupings of statements

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(i.e., cheerfulness, self-confidence, need for sleep, talkative, social activity). A score of 6+

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is suggestive of clinically significant hypo/mania (85.5% sensitivity, 87.3% specificity;

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Altman et al., 1997). The AMS has been used widely in research and clinical practice

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(Smith, Cornelius, Warnock, Tacchi, & Taylor, 2007).

Young Mania Rating Scale. The MRS (Young, Biggs, Ziegler, & Meyer,

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(1978) follows the format of the HAM-D and is intended to be administered as part

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of a structured clinical interview. A severity rating is assigned to each of the eleven items, based on the patient’s reports and the clinician's observations during the

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interview, with the emphasis on the latter (Young et al., 1978). Satisfaction with Life (SWL) Scale. The SWL (Diener, Emmons, Larsen, & Griffin, 1985) measures perceived quality of life on the basis of person-specific criteria. Respondents compare their current circumstances against subjective standards to arrive at a global appraisal of life satisfaction (Diener, 2000). Participants respond to five questions with seven response alternatives. Good internal consistency has been reported with young and older adults with BD (α = .89; O’Rourke et al., 2018). Existing research indicates that depression is associated with lower SWL but life satisfaction appears unrelated to hypo/manic symptoms of BD (O’Rourke et al., 2016). Data analyses. To establish the clinical validity of the BDSx, we compared response levels between those presenting with and without clinically significant BD symptomology

Journal Pre-proof (e.g., hypo/manic or major depressive episodes). We then identified optimal cut-off points to calculate sensitivity and specificity for both BDSx depressive and hypo/manic subscales. Clinician responses to the MRS and HAMD-24 were also compared to the BDSx. To examine the concurrent and discriminant validity, we computed correlation coefficients between BDSx subscales and the HAMD-6 (self-report), Altman Self-Rating Mania Scale, and the Satisfaction with Life Scale. Analyses were computed with SPSS version 25.

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Results

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One participant was excluded from analysis due to erratic responses to self-report instruments. Another did not complete the BDSx and was also excluded. The final sample

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included 26 men and 32 women, 43.62 years of age on average (SD = 13.2; range 21.5 –

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69.6 years). All patients were diagnosed with BD I, 20 years ago on average (SD = 12.7;

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range 2.6 – 54.6) at 23.8 years of age (SD = 7.7; range 15-50). Demographic and clinical

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information are presented in Table 1.

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TABLE ONE HERE

Eighteen participants had completed high school, 20 had some post-secondary training, 15 held a BA and 6 had post graduate degrees. Most participants were employed at least part-time (31); others were students (6), homemakers (9), retired (9), or unemployed (4). See Table 2.

TABLE TWO HERE

As expected in an outpatient sample, pharmacotherapy was near universal. Fortynine of 58 patients were prescribed mood stabilizers (35 lithium, 9 valproate, and/or 14

Journal Pre-proof lamotrigine), while 4 patients were on antidepressants, and 34 treated with dopamine blockers (clopazine 9, olanzapine 7, risperidone 5, quietapine 6, FGAs 7). Total numbers exceed sample size due to polypharmacy. BDSx Responses. Consistent with the original BDSx, Hebrew responses to the cognitive and somatic factors were moderately correlated (r =.65, p<.01), as were responses to the two hypo/mania factors (affrontive, elation/loss of insight; r =.57, p<.01). Again consistent with the English-speaking patients, affrontive symptoms of hypo/manic were correlated with both cognitive (r =.26, p=.06) and somatic symptoms of depression (r

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=.27, p<.05). Yet elation/loss of insight was uncorrelated with both depression factors

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(cognitive r =.07, ns; somatic r =.04, ns). This suggests that affrontive symptoms of

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hypo/mania present in mixed-states, not elation/loss of insight (O’Rourke et al., 2016;

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O’Rourke et al., 2018).

BDSx versus clinical diagnoses. The clinic psychiatrist determined that 7 of 58

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patients (12%) presented with clinically significant mania or hypomania (CGI; Spearing et

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al., 1997). These patients reported significantly higher BDSx mania subscale responses (4.14 vs. 1.92, t[56]=2.33, p=.02). As expected, those diagnosed as currently hypo/manic

t[56]=.82, ns).

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did not report higher BDSx depression scores than euthymic patients (3.29 vs. 4.76,

Eight other patients (14%) were identified as currently depressed. These patients reported significantly higher BDSx responses to the both cognitive (t[56]=5.25, p<.01) and somatic depression factors (t[56] = 3.52, p=.01) as well as combined depression subscale scores, t[56]=5.02, p<.01. Hypo/mania subscale responses did not significantly differ between depressed and euthymic patients (3.00 vs. 2.06, t[56]=1.01, ns). No patient received a mixed-state diagnosis.

BDSx Sensitivity and Specificity. Seven of 8 depressed patients reported BDSx depression subscale scores 6+ indicating 88% sensitivity (M=10.75, SD=4.40; t[56] = 5.02,

Journal Pre-proof p <.01). Conversely, 39 of 51 euthymic patients provided responses below this threshold indicating 76% specificity, M=3.60, SD=3.64; 2(df=1)=12.96, p<.01. Four of 7 hypo/manic patients provided BDSx hypo/mania subscale responses 5+ indicating 57% sensitivity (M=4.14, SD=3.08; t[56]=2.33, p<.05). Conversely, 47 of 52 euthymic patients provided responses below this threshold indicating 90% specificity, M=1.92, SD=2.26; 2(df=1)=10.78, p<.01. Concurrent and Discriminant Validity

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BDSx vs. self-report scales. BDSx depression subscale scores was strongly

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correlated with the self-report HAMD-6 responses (r =.75, p<.01). As expected,

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depression subscale scores were significantly and inversely associated with life

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satisfaction (r =-.53, p<.01).

Responses to the BDSx hypo/mania subscale were moderately correlated with the

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Altman Self-Rating Mania Scale (r =.35, p<.01). And consistent with the English BDSx, hypo/mania subscale scores were uncorrelated with satisfaction with life (r =-.11, ns).

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Hebrew BDSx.

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These findings support the concurrent and discriminant validity of responses to the

BDSx vs. clinician rating scales. BDSx depression subscale scores were strongly correlated with the HAMD-17 completed (blindly) by the psychiatrist (r =.72, p<.01). Mania subscale scores were moderately correlated with the Young Mania Rating Scale (r =.44, p=.01). These findings providing further support for the construct validity of BDSx responses. Discussion We found that responses to the Hebrew version of the BDSx demonstrate good psychometric properties. Similar to the original English version of the scale (O’Rourke et al., 2016; O’Rourke et al., 2016), we found good concurrent validity compared to established self-report scales, and construct validity compared to clinician responses to

Journal Pre-proof patient rating scales and diagnoses of BD mood episodes. These findings emerged for both BDSx depression and hypo/mania subscales. As we noted, affrontive symptoms of mania correlate with both cognitive and somatic depression factors consistent with the mixed features clinical presentation of BD (APA, 2013). This pattern of correlations has also been reported with the English version of the BDSx (O’Rourke et al., 2016; O’Rourke et al., 2018). These symptoms are consistent with our clinical observation that some BD patients

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exhibit an angrier, bitter and more externalizing type of depression; more hostile and

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suspicious than a typical presentation, often without other symptoms of hypo/mania (e.g.,

described in DSM 5 (APA, 2013).

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euphoria/loss of insight). More research is needed as this cluster of symptoms is not

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In large degree, this is why the BDSx hypo/mania subscale is moderately but not

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strongly correlated with self-report responses to the Altman Self-Rating Mania Scale; the latter more closely parallels existing BD diagnostic criteria.

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Yet recent research with cohabiting spouses of BD patients (O’Rourke & King, 2019) reports that BDSx affrontive symptoms are significantly correlated with negative partner

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mood (r =.38, p<.01) unlike elation/loss of insight (r =.02, p=.71). Moreover, the magnitude of association between affrontive symptoms and negative partner mood is greater when couples are physically together than apart (i.e., same vs. different GPS coordinates; r =.41, p<.01, r =.12, ns, respectively). One limitation of this study is that our sample size was insufficient to test the factorial validity of the BDSx; replication with larger samples recruited from other clinical settings is required. Also, all participants recruited for this study were diagnosed with BD I; future research should replicate these findings with patients diagnosed with BD II and cyclothymia. Yet this study is the first to demonstrate the clinical validity of the BDSx with ambulatory bipolar outpatients. We replicate earlier findings with the original scale demonstrating good psychometric properties. And we report findings in support of the

Journal Pre-proof BDSx relative to clinician-completed scales. Moreover, sensitivity (and specificity) relative to depression diagnoses is ideal at 88% (and 76%) for the BDSx depression subscale, but less so for the hypo/mania subscale (57% & 90%, respectively). The results of this study support the psychometric properties of a Hebrew version of the BDSx. This enables cross-national research comparting BD symptom levels and variability over time between participants in Israel and English-speaking countries (e.g., U.S., U.K., Australia). These findings add to a growing body of research indicating that the BDSx is a rapid, reliable and valid measure of BD symptoms. The BDSx can also be used

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as part of a comprehensive care management program to regularly measure symptom

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levels and variability over time to foster self-awareness, self-care and treatment

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adherence.

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References

Altman, E.G., Hedeker, D., Peterson, J.L., & Davis, J.M. (1997). The Altman self-rating

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mania scale. Biological Psychiatry, 42(10), 948-955. doi:10.1016/S0006-

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American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Washington, DC: Author.

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Bagby, R.M., Ryder, A.G., Schuller, D.R., & Marshall, M.B. (2004). The Hamilton Depression Rating Scale: has the gold standard become a lead weight? American Journal of Psychiatry, 161(12), 2163-2177. doi:10.1176/appi.ajp161.12.2163 Bachner, Y.G., O’Rourke, N., Goldfracht, M., Bech, P., & Ayalon, L. (2013). Psychometric properties of responses by clinicians and older adults to a 6-item Hebrew version of the Hamilton Depression Rating Scale (HAM-D 6). BMC Psychiatry, 13(1), 2. doi:10.1186/1471-244X-13-2 da Silva, R.D.A., Mograbi, D.C., Silveira, L.A.S., Nunes, A.L.S., Novis, F.D., LandeiraFernandez, J., & Cheniaux, E. (2015). Insight across the different mood states of bipolar disorder. Psychiatric Quarterly, 86(3), 395-405. doi:10.1007/s11126-0159340-z Diener, E.D. (2000). Subjective well-being: The science of happiness and a proposal for a national index. American Psychologist, 55(1), 34-42. doi:10.1037/0003-066X.55.1.34

Journal Pre-proof Diener, E.D., Emmons, R.A., Larsen, R.J., & Griffin, S. (1985). The Satisfaction with Life Scale. Journal of Personality Assessment, 49(1), 71-75. doi:10.1207/s15327752jpa4901_13 Entsuah, R., Shaffer, M., & Zhang, J. (2002). A critical examination of the sensitivity of unidimensional subscales derived from the Hamilton Depression Rating Scale to antidepressant drug effects. Journal of Psychiatric Research, 36(6), 437-448. doi:10.1016/S0022-3956(02)00024-9 Eremenco, S., Pease, S., Mann, S., & Berry, P. (2018). Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. Journal of Patient Reported Outcomes, 2(1), 1-11. doi:10.1186/s41687-

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Geddes, J.R., & Miklowitz, D.J. (2013). Treatment of bipolar disorder. Lancet, 381(9878),

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1672-1682. doi:10.1016/S0140-6736(13)60857-0

Hamilton, M. (1960). A rating scale for depression. Journal of Neurology, Neurosurgery,

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and Psychiatry, 23(1), 56-62.

King, D.B., Sixsmith, A., Yaghoubi Shahir, H., Sadeghi, M., Razmara, M., & O’Rourke, N.

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(2016). Developing an ecological momentary sampling tool to measure movement patterns and psychiatric symptom variability. Gerontechnology, 14, 105-109.

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O’Rourke, N., Bachner, Y.G., Canham, S.L., Sixsmith, A., & the BADAS Study Team (2018). Measurement equivalence of the BDSx scale with young and older adults with

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bipolar disorder. Psychiatry Research, 263, 245-249. doi:10.1016/j.psychres.2017.10.024 O’Rourke, N., & King, D.B. (July, 2019). Within-couple analyses of bipolar disorder symptoms and partner mood over time. Paper presented at the European Congress on Psychology, Moscow, Russia. O’Rourke, N., Sixsmith, A., King, D.B., Yaghoubi-Shahir, H., Canham, S.L., & the BADAS Study Team (2016). Development and validation of the BDSx: A brief measure of mood and symptom variability for use with adults with bipolar disorder. International Journal of Bipolar Disorders, 4(1), 8. doi:10.1186/s40345-016-0048-2 Osher, Y., Bersudsky, Y., & Belmaker, R.H. (2010). The new lithium clinic. Neuropsychobiology, 62(1), 17-26. doi:10.1159/000314306 Schaffer, A., Cairney, J., Cheung, A., Veldhuizen, S., & Levitt, A. (2006). Community survey of bipolar disorder in Canada: Lifetime prevalence and illness characteristics. Canadian Journal of Psychiatry, 51(1), 9-16. doi:10.1177/070674370605100104

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Spearing, M.K., Post, R.M., Leverich, G.S., Brandt, D., & Nolen, W. (1997). Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGIBP. Psychiatry Research, 73(3), 159-171. doi:10.1016/S0165-1781(97)00123-6 Young, R.C., Biggs, J.T., Ziegler, V.E., & Meyer, D.A. (1978). A rating scale for mania: Reliability, validity and sensitivity. British Journal of Psychiatry, 135(5), 429-435.

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doi:10.1192/bjp.133.5.429

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4-Factor Model of BDSx Responses

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Maximum

M

SD

α

21.5

69.6

43.62

13.2

--

Age at BD Onset

15

50

23.8

7.6

--

Years since BD Dx

2.6

54.6

19.83

12.7

--

BDSx - Depression

0

18

4.62

4.4

.90

BDSx - Hypo/mania

0

9

2.19

2.45

.76

HAMD-6

0

18

4.22

4.6

.84

Altman Mania

0

11

1.98

2.6

.74

5

35

21.62

7.5

.88

0

15

2.31

3.8

.88

0

20

0.76

2.9

.90

Age

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Minimum

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Demographic and clinical variables, N = 58

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Self-report scales

Clinician completed scales

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HAMD-17

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Satisfaction with Life

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Young Mania Rating Scale

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BDSx factor scores, Hebrew version

Maximum

M

SD

α

BDSx Depression - cognitive

0

10

2.05

2.7

.86

BDSx Depression - somatic

0

8

2.53

2.2

.85

BDSx Hypo/mania - affrontive

0

4

.67

1.1

.60

BDSx Hypo/mania - elation

0

6

1.7

.65

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Minimum

1.52

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Highlights The Bipolar Disorder Symptom Scale (BDSx) measures two depression, two hypo/mania factors Affrontive symptoms of hypo/mania correlate with both depression factors  12% and 14% of BD outpatients with elevated depression and hypo/mania, respectively Sensitivity high for BDSx depression subscale (88%), yet lower for hypo/mania (57%)

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 Specificity high for both BDSx depression (76%) and BDSx hypo/mania subscales (90%)